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At-Home Cardiac Rehabilitation for Adolescents at Risk for Heart Failure

RecruitingNAAges 0 Years - 21 YearsAllChildren's Hospital Los Angeles
NCT06826534 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to explore the impact that an at-home cardio-oncology rehabilitation (CORE) may have on short-term cardiovascular fitness and psychosocial wellness in pediatric cancer survivors. The main question it aims to answer are * To evaluate the efficacy of an at-home CORE model on short-term cardiovascular fitness and psychosocial wellbeing in adolescent cancer survivors. * To evaluate the exercise adherence rate among adolescents at risk for heart failure and assess barriers to compliance. * To explore which specific CORE resources are of most value to patients in creating sustainable healthy lifestyle modifications. * Hypothesis: Pediatric cancer survivors who implement exercise and dietary recommendations will demonstrate improvement in cardiovascular fitness and general wellness. A multidisciplinary team approach can facilitate adherence to a moderately ri

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📋 Eligibility rules (as published)
INCLUSION CRITERIA * Patients aged of 10-21 years at enrollment * Parent/legal guardian available for consent (if applicable), and patient available for assent and consent * History of anthracycline exposure +/- radiation * Currently in remission, with at least 6 months off chemotherapy * Able to perform CPET * Baseline CPET with VO2 \<80% (at start of study, or CPET at CHLA after January 2020) * Smartphone compatible with Fitbit (own or parent/legal guardian's) * Ability to complete and send diary and Fitbit information on a weekly basis * Ability to participate in monthly virtual check-in visits * Baseline activity prior to intervention \<30min/day, 2x/week EXCLUSION CRITERIA * Inability to obtain consent/assent * Unable to accurately perform quality of life survey independently * No other primary medical diagnosis (e.g., Down Syndrome, Wolff-Parkinson-White Syndrome, congenital heart disease) or history of cardiothoracic surgery * Contraindication to moderate activity (\>3 METs). Examples include history of malignant arrhythmias, exercise-induced syncope, severe symptoms of HF (NYHA IV, ACC/AHA Stage D) * Unable to perform CPET, echocardiogram, EKG, or obtain laboratory studies * Unable to perform mild activity for at least 0.5h/day and at least 2x/week * Unable to come to hospital for study visits at 0 and 6 months * Unable to complete study-related surveys * Unable to complete and send diary and Fitbit information on a weekly basis * Unable to check-in monthly on virtual platform * On beta blockade * Pregnancy
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What it tests

  • Cardio-oncology rehabilitation
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Where

1 site
Children's Hospital Los Angeles
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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